Comparison of the effect of dexamethasone and ondansetron on nausea and vomiting after upper gastrointestinal endoscopy in adults
Design
single-blinded randomized controlled clinical trial with parallel groups, phase 3 trial on 102 patients, randomization list through www. sealedenvelope.com
Settings and conduct
Patients of groups I and II of the ASA criterion who are candidates for upper gastrointestinal endoscopy will be randomly divided into 3 groups: receiving dexamethasone, ondansetron and the control group. Before upper gastrointestinal endoscopy, when the level of anesthesia is sufficient, 8 mg of dexamethasone will be injected intravenously to the patients in the dexamethasone group and 4 mg of intravenous ondansetron will be injected to the patients in the ondansetron group, and the patients in the control group will receive an equal volume of normal saline.
Participants/Inclusion and exclusion criteria
Patients 18 to 70 years who are candidates for endoscopy, with no history of sensitivity to the drugs used in the study, no history of chemotherapy and malignancy, and no use of anti-nausea and vomiting drugs up to 24 hours before the study
Intervention groups
Intervention group (dexamethasone): receiving 8mg of dexamethasone intravenously
Intervention group (ondansetron): receiving 4mg of ondansetron intravenously
Control group: receiving normal saline
Main outcome variables
Nausea and vomiting, cough, sore throat
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230926059530N1
Registration date:2023-10-24, 1402/08/02
Registration timing:registered_while_recruiting
Last update:2023-10-24, 1402/08/02
Update count:0
Registration date
2023-10-24, 1402/08/02
Registrant information
Name
Ali Zamanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4251 0991
Email address
alizamanian9674@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-06, 1402/07/14
Expected recruitment end date
2023-11-05, 1402/08/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Dexamethasone with Ondansetron on nausea and vomiting in adults undergoing upper GI endoscopy
Public title
Comparison of the effect of Dexamethasone with Ondansetron on nausea and vomiting in adults undergoing upper GI endoscopy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients between 18 and 70 years of age, group I and II criteria of ASA candidate for elective UGIE diagnosis based on the opinion of a gastroenterologist
Exclusion criteria:
No history of allergy to the drugs used in the study
No history of chemotherapy
Not receiving any anti-nausea medication 24 hours before endoscopy
No history of malignancy
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to three groups receiving ondansetron, dexamethasone and the control group using the six block method and using the randomization list taken from the website www.sealedenvelope.com.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Qutb Ravandi Boulevard - Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2023-08-13, 1402/05/22
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1402.123
Health conditions studied
1
Description of health condition studied
Diseases of the digestive system
ICD-10 code
K00-K93
ICD-10 code description
Diseases of the digestive system
Primary outcomes
1
Description
nausea and vomiting
Timepoint
After upper gastrointestinal endoscopy
Method of measurement
Patient self-expression
2
Description
cough
Timepoint
After upper gastrointestinal endoscopy
Method of measurement
Patient self-expression
3
Description
Sore throat
Timepoint
After upper gastrointestinal endoscopy
Method of measurement
Patient self-expression
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receive 8mg of intravenous dexamethasone before upper gastrointestinal endoscopy
Category
Prevention
2
Description
Intervention group: Receive 8mg of intravenous Ondansetron before upper gastrointestinal endoscopy
Category
Prevention
3
Description
Control group: Receiving normal saline before upper gastrointestinal endoscopy